Marinomed Biotech AG announces progress with Tacrolimus Eyedrops for Entry into the Compounding Market

 Marinomed Biotech AG announces progress with Tacrolimus Eyedrops for Entry into the Compounding Market

• Strategic Commercial Milestone: Marinomed has chosen its first product for the compounding market, Tacrolimus eyedrops. First revenues from partners are expected for Q4/2026 or beginning of 2027.
• Strong Clinical Validation: Feedback from a global network of leading ophthalmologists across USA and Europe confirms a high medical need for Tacrolimus to treat refractory ocular inflammation and to reduce long-term steroid dependency.

Korneuburg, Austria, May 11^th, 2026 – Marinomed Biotech AG (VSE:MARI), a healthcare-focused innovator committed to improving patient outcomes, (the "Company"), today announced that Tacrolimus eyedrops are the prime candidate for entering the compounding business based on input from ophthalmologists worldwide. Marinomed expects first revenues in Q4 2026 or beginning of 2027 from partners and fast growth in 2027. Marinomed has gathered extensive feedback from key opinion leaders worldwide in the field of inflammatory ocular surface disease. The experts confirmed significant unmet medical need for Tacrolimus eyedrops in specific indications and for certain patient populations that cannot be adequately addressed by existing therapies. Compounded Tacrolimus eyedrops based on the Marinosolv technology could close this gap and is also an interesting commercial opportunity.

Strategic Entry into the Compounding Market Marinomed’s entry into the compounding market represents a key commercial milestone in the Company’s strategy to monetize its proprietary Marinosolv® platform. By focusing on specialized compounding, Marinomed can address niche patient populations and high-need therapeutic areas more rapidly than through traditional drug development pathways. This strategy allows for faster market access and provides a flexible commercial model to deliver innovative treatments to patients who have exhausted standard-of-care options. In addition, the availability of Marinosolv-based Tacrolimus eyedrops as a compounded version is expected to support the development of Tacrosolv as licensed pharmaceutical product in the future.

Ophthalmologists Confirm Significant Therapeutic Gap To support the development of Tacrosolv Marinomed has established a network of renowned specialists in the field of inflammatory eye diseases from leading Universities in the USA, Germany, France, Italy, Spain and Austria:

All experts confirmed that Tacrolimus eyedrops address a critical medical need for patients who do not respond to existing marketed products or suffer from intolerable local side effects. Furthermore, the availability of tolerable Tacrolimus formulation was cited as a beneficial way to reduce the long-term use of steroids.

Superiority of the Marinosolv® Formulation

Currently, clinicians must rely on suboptimal alternatives, including the off-label use of dermatological creams, which can cause significant ocular irritation, imported products from Asia, or oil-based compounded formulations that are often poorly tolerated by patients.

Marinomed’s solution, based on the Marinosolv® technology, offers a clear aqueous eyedrop. Notably, this formulation remains highly effective at a 10-fold lower concentration than existing creams or imported products.

Broad Application Potential While individual specialists identified different primary uses, the collective feedback highlighted a vast range of potential indications, particular those currently not addressed by existing drugs and niche indications:

• Ocular Graft-versus-host disease (GvHD)
• Persistent iritis and Mooren´s ulcer
• Mucous membrane pemphigoid and Thygeson´s keratitis
• Corneal transplant rejection and autoimmune corneal or scleral melts

In addition, physicians also would consider the use of Tacrolimus eyedrops for patients that are refractory to corticosteroids or other immunosuppressants in case of

• Vernal, seasonal, and atopic keratoconjunctivitis or
• Severe Dry Eye Disease (including Sjögren’s syndrome)

"Our strategy to enter the compounding market is a logical evolution for Marinomed, allowing us to leverage our Marinosolv® technology and to generate revenues from Q4/2026 onwards," said Andreas Grassauer, CEO at Marinomed. "The feedback from these world-class institutions confirms that our aqueous Tacrolimus formulation is not just a preference, but a necessity for patients suffering from chronic, painful ocular inflammations. This approach bridges the gap between innovative technology and immediate clinical application."

About Marinomed Biotech AG

Marinomed Biotech AG is an Austrian, science-based biotech company with a growing development pipeline. The Company develops innovative patent-protected products based on the Marinosolv® platform. The Marinosolv® technology improves the solubility and bioavailability of hardly soluble compounds and is used to develop new therapeutics for autoreactive immune disorders. The Company is headquartered in Korneuburg, Austria, and is listed on the Vienna Stock Exchange (VSE:MARI). For further information, please visit: https://www.marinomed.com.

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